Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— UCanADA  

Official title:

A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506179
• Other study ID #: P15-325
• Status: Completed
• Start date: August 18, 2015
• Est. completion date: February 10, 2020

Study information

• Verified date: January 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must voluntarily sign and date a patient authorization.
• Patient must be = 18 years of age.
• Patient must have confirmed diagnosis of UC.
• Patient must have:

1. a Mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or

2. a Mayo rectal bleeding subscore = 2 and a calprotectin value greater than 250 µg/gr.

• Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
• If the patient was previously treated with vedolizumab or any anti-TNF agent (except adalimumab), an appropriate washout has taken place as per routine practice.

Exclusion Criteria:

• Patient has previously received adalimumab.
• Patient has previously used infliximab or any anti-TNF agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
• Patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
• Patient with a current diagnosis of indeterminate colitis, ulcerative proctitis only, or with a current diagnosis and/or have a history of Crohn's disease.
• Patient with other tumor necrosis factor (TNF) immune-modulated disease.
• Patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
• A female patient is pregnant or breast-feeding.
• Patient is currently participating in another prospective study including controlled clinical trials and observational studies

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Canada	Bellini Medicine Professional /ID# 144241	Brampton	Ontario
Canada	University of Calgary /ID# 144032	Calgary	Alberta
Canada	Zeidler Ledcor Centre /ID# 145973	Edmonton	Alberta
Canada	Dr. Everett Chalmers Reg Hosp. /ID# 136534	Fredericton	New Brunswick
Canada	Hopital Hotel-Dieu de Levis /ID# 137099	Levis	Quebec
Canada	CHUM - Hopital Saint-Luc /ID# 139393	Montreal	Quebec
Canada	Clinique MEDI-CLE /ID# 153690	Montreal	Quebec
Canada	Hospital Maisonneuve-Rosemont /ID# 137336	Montreal	Quebec
Canada	McGill Univ HC /ID# 136821	Montreal	Quebec
Canada	Columbia Gastro Mgmnt Ltd /ID# 136820	New Westminster	British Columbia
Canada	Oshawa Clinic /ID# 144364	Oshawa	Ontario
Canada	The Ottawa Hospital /ID# 139392	Ottawa	Ontario
Canada	CHU de Quebec-Universite Laval /ID# 147557	Quebec City	Quebec
Canada	Royal Univ. Hosp, Saskatoon,CA /ID# 137838	Saskatoon	Saskatchewan
Canada	CHUS - Hopital Fleurimont /ID# 137840	Sherbrooke	Quebec
Canada	Dr Chadwick Ian Williams Professional Corporation /ID# 144802	St. John	New Brunswick
Canada	Kensington Screening Clinic /ID# 141106	Toronto	Ontario
Canada	Mount Sinai Hosp.-Toronto /ID# 141108	Toronto	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 141107	Vancouver	British Columbia
Canada	Discovery Clinical Services /ID# 144102	Victoria	British Columbia
Canada	Percuro Clinical Research, Ltd /ID# 136533	Victoria	British Columbia
Canada	Dr O Tarabain Medicine Prof Corp /ID# 144034	Windsor	Ontario
Canada	Dr. Rahman Bacchus Med. Corp. /ID# 141780	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Cato Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in depressive symptoms at Week 52	It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in depressive symptoms at Week 8	It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).	From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in the proportion of patients with PHQ-9 >= 10	The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52.	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in Disability	It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in Overall quality of life	It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in Ulcerative Colitis (UC)-specific quality of life	It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in Fatigue	It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in Sleep impairment,	It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in Work productivity	The change from baseline in work productivity is assessed at week 8 and 52.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Assessing Simple Clinical Colitis Activity Index (SCCAI)	SCCAI is used to access response and remission rates.	Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in Fecal Calprotectin levels	The change from baseline in Fecal Calprotectin levels will be assessed.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Mayo endoscopic sub-score	Mayo endoscopic sub-score will be assessed.	Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Proportion of patients with Complications including hospitalization and surgery	The proportion of patients with complications including hospitalization and surgery will be assessed.	At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Proportion of patients on steroids	The proportion of patients on steroids will be assessed.	At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary	Change from baseline in Physician's Global Assessment (PGA)	The change from baseline in Physician's Global Assessment (PGA) will be assessed.	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

External Links

•   clinical study report synopsis